India Pharma Outlook Team | Monday, 17 August 2026
Lung cancer trial development at AstraZeneca has hit a setback. The company discontinued its Phase III eVOLVE-Lung02 study of volrustomig with chemotherapy in metastatic non-small cell lung cancer (NSCLC).
An independent data monitoring committee found that the combination was unlikely to meet its primary endpoints.
These included progression-free survival and overall survival in patients whose tumors lacked PD-L1.
However, AstraZeneca reported positive results from two other late-stage studies involving Tagrisso with Orpathys and Enhertu. The company will also continue testing volrustomig in other cancers.
AstraZeneca decided to stop the lung cancer trial following a planned review of data by an independent Data Monitoring Committee. The committee concluded that volrustomig combined with chemotherapy would likely fail to achieve either primary endpoint, progression-free survival or overall survival. The trial focused on patients with metastatic NSCLC whose tumors lacked PD-L1.
The eVOLVE-Lung02 study compared volrustomig plus chemotherapy against pembrolizumab plus chemotherapy as a first-line treatment. AstraZeneca’s clinical trial information identifies the study as a global Phase III program for metastatic NSCLC.
The company said the safety profile of volrustomig with chemotherapy remained consistent with the known profiles of the individual medicines. The review identified no new safety signals.
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The termination does not end AstraZeneca’s development program for volrustomig. The company will continue other Phase III trials involving the drug in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.
Volrustomig belongs to a class of bispecific antibodies designed to target two immune checkpoints, PD-1 and CTLA-4. The approach aims to activate the immune system against cancer through two pathways. AstraZeneca continues to list volrustomig among its clinical-stage oncology programs.
The company’s decision therefore represents a setback for one specific lung cancer indication rather than a complete withdrawal of the drug from clinical development.
The latest lung cancer trial setback arrived alongside encouraging results from two other AstraZeneca programs. The company reported positive results from the Phase III SAFFRON trial, which evaluated Tagrisso with Orpathys in patients with EGFR-mutated NSCLC. The combination achieved statistically significant and clinically meaningful improvements in both progression-free survival and overall survival.
AstraZeneca also reported positive results from the Phase III DESTINY-Lung04 trial evaluating Enhertu in patients with HER2-mutant, non-squamous NSCLC. The study showed a statistically significant and clinically meaningful improvement in progression-free survival as a first-line treatment.
Enhertu, or trastuzumab deruxtecan, emerged from collaboration between AstraZeneca and Daiichi Sankyo, adding another important program to AstraZeneca’s oncology portfolio.
The discontinued lung cancer trial adds to a series of recent development challenges for AstraZeneca. Reuters reported setbacks involving Wainua in a late-stage heart disease trial, camizestrant following a US rejection linked to trial-design issues, and Ultomiris in a late-stage rare disease study.
Despite these setbacks, AstraZeneca continues to target USD 80 billion in annual revenue by 2030. The company expects up to 20 new drug launches to support that ambition. Its oncology portfolio remains central to the strategy, with lung cancer representing one of its major therapeutic areas.
The discontinued lung cancer trial highlights the challenges pharmaceutical companies face when advancing immuno-oncology combinations into late-stage development. AstraZeneca’s broader results also show that the company continues to make progress across different mechanisms and patient populations.
For volrustomig, the focus now shifts to its remaining Phase III programs. For AstraZeneca, the positive Tagrisso-Orpathys and Enhertu results provide important counterpoints to the eVOLVE-Lung02 setback as the company works to strengthen its oncology pipeline and maintain its long-term growth ambitions.
